NCT04864665已完成不适用
A Prospective, Multicentre Before and After Study to Evaluate the Effects of a Formula With Prebiotics and Milk Fat, on the Gut Health of Chinese Infants and Young Children
Danone Nutricia6 个研究点 分布在 1 个国家目标入组 455 人开始时间: 2021年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 455
- 试验地点
- 6
- 主要终点
- Change in stool bifidobacteria level
研究概览
简要总结
The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood. It can inhibit the growth of pathogenic bacteria, prevent the occurrence of diseases and improve the child's quality of life. It is therefore important to regulate the microbiota balance in infants and young children.
This objective of this post-launch study is to evaluate the effects of a formula with prebiotics and milk fat on the gut microbiota and stool characteristics of healthy Chinese infants and young children. The duration of the study for each participant is 32 days and includes 3 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The gestational age was 37-42 weeks at birth;
- •Birth weight ≥2,500 g and ≤ 4,500 g;
- •Chinese nationality;
- •Weight and height are within normal range (i.e. WHO Child Growth Standards
- •No relocation across provinces/ cities in the past 1 year and no plans to relocate during the study period.
- •Breastfeeding reference: breastfeeding at the time of enrollment, and the mother intends to continue breastfeeding throughout the study period;
- •Intervention arm: formula feeding / habitual milk drinking (formula milk, milk and other dairy products) at the time of enrollment, and willing to change from the original milk powder / dairy product to the study formula, and consume it as instructed during the study period;
- •The child's parent(s) / guardian has access to a mobile phone on which the secure digital WeChat platform can be installed and used, connect to the network, take photographs and record defecation, and complete questionnaires during the study;
- •The child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study.
- •The child's parent(s) / guardians can be contacted directly by telephone or WeChat;
排除标准
- •Neonatal asphyxia at birth;
- •Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact study outcomes;
- •Cognitive and developmental disorders;
- •Antibiotic usage up to 2 weeks before enrollment;
- •Ongoing antibiotic treatment;
- •Taking probiotic supplements or formula with probiotics up to 1 month before enrollment;
- •Participation in other clinical trials;
- •Parent(s)' / guardian's refusal to participate in the study;
- •Known or suspected allergy to cow milk, soy or fish
结局指标
主要结局
Change in stool bifidobacteria level
时间窗: 32 days
Stool sample analysis
次要结局
- Change in gastrointestinal tolerance(32 days)
- Satisfaction with the study product(32 days)
- Change in stool lactobacillus level(32 days)
- Change in stool characteristics(32 days)
研究者
研究点 (6)
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